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510(k) K860557

LATEX R. TYPHI by Health Research, Inc. — Product Code GPM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1986
Date Received
February 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Murine Typhus Fever
Device Class
Class I
Regulation Number
866.3500
Review Panel
MI
Submission Type

Other clearances by Health Research, Inc.

  • K872129 — LATEX R. CONORII (August 19, 1987)
  • K843794 — LATEX-R RICKETTSII (January 4, 1985)